DeviceClearance

Product code SAB— General, Plastic Surgery

MIRA Surgical System

Classification name
Table Mounted Miniaturized Electromechanical Surgical System
Device class
Class 2
Regulation
21 CFR 878.4962
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms”

— U.S. Food and Drug Administration, device classification record for product code SAB under 21 CFR 878.4962, via openFDA

Market context for product code SAB

FDA has cleared 2 devices under product code SAB between 2024 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SAB

Recent clearances under product code SAB

Data sourced from openFDA. This site is unofficial and independent of the FDA.